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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK120041 Letter

 

Fenwal, Inc.

Attention: Mr. John Maibauer
Three Corporate Drive
Lake Zurich, IL 60047
 
Re:    BK120041
         Trade Name: AMICUS Separator System; ALYX Component System
         Regulation Number: 21 CFR 864.9245
         Regulation Name: Automated blood Cell separator
         Regulatory Class: Class II
Product Code: GKT
Dated: September 25, 2012
Received: September 27, 2012
 
Dear Mr. Maibauer:
 
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
 
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
 
Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
 
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance. Also, please note the regulation entitled, ²Misbranding by reference to premarket notification² (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 
 
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638‑2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
 
If you have any questions concerning the contents of the letter, please contact the Regulatory Project Manager, Alisha Miller, at (301) 827-3927. 
 
 
Sincerely yours,
 
 /s/
 
Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics
    Evaluation and Research
 
                                                                       
Enclosures:
Indications for Use--
AMICUS Separator System
ALYX Component Collection System

 


 

                                                       Indications for Use                                                                            
510(k) Number: BK120041
 
Device Name: AMICUS Separator System
 
Indications for Use:
 
The AMICUS separator system is an automated blood cell separator indicated for the collection of blood components and mononuclear cells.
 
The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post platelet count greater than or equal to 100,000 platelets/μL.
 
Depending on the AMICUS separator system apheresis kit used in the collection of products, the AMICUS separator system has been cleared to collect:
 
  • Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)
     
  • Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double or triple units)
  • Red Blood Cells, Leukocytes Reduced (by apheresis)
  • Mononuclear Cells
  • Therapeutic Plasma Exchange (TPE)
  • Plasma
  • ­       Fresh Frozen Plasma
    • Must be prepared and placed in a freezer at -18° C or colder within 8 hours of collection.
  • ­       Source Plasma
  • ­       Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
    • Must be stored at 1-6°C within 8 hours of collections and prepared and frozen within 24 hours after phlebotomy.
    • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
    • Plasma Frozen Within 24 Hours after Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24)
    • Can be stored at room temperature for up to 24 hours after collection. Product must be prepared and frozen within 24 hours after phlebotomy.
    • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
       
Platelets Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet, Pheresis, Platelet Additive Solution (lnterSol) (single, double, and triple units). 

 


 

Indications for Use
 
510(k) Number: BK120041
 
Device Name: ALYX Component Collection System
 
Indications for Use:
 
The ALYX Component Collection System is intended for use in blood collection establishments to collect and separate whole blood into its components.
 
Depending on the ALYX Component Collection system apheresis kit used in the collection of products, the ALYX Component Collection system has been cleared for:
  • Concurrent collection of two units of Red Blood Cells (2RBC), Leukocytes Reduced 
    -          Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted
  • Concurrent collection of two units of Red Blood Cells (2RBC), Non-Leukocytes Reduced
    -          Single Unit Recovery (One Unit of Red Blood Cells, Non-Leukocytes Reduced) permitted
  • Concurrent collection of One Unit of Red Blood Cells, Leukocytes Reduced, and Plasma as
    -          Fresh Frozen Plasma,
    • Must be prepared and placed in a freezer at -18°C or colder within 8 hours of collection.
      -          Source Plasma
      -          Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
    • Must be stored at 1-6°C within 8 hours of collection and prepared and frozen within 24 hours after phlebotomy.
    • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
      -          Plasma Frozen Within 24 Hours After Phlebotomy Held At Room Temperature Up To 24 Hours After Phlebotomy (PF24RT24)
    • Can be stored at room temperature for up to 24 hours after collection. Product must be prepared and frozen within 24 hours after phlebotomy.
    • Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
  • Collection of Plasma as
    -          Source Plasma